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Pediatric Electrode, Model PAD Pro 2602

FDA 510(k)

Class III (US FDA 510(k))

510(k) K002280

by Medical Devices Inc.

Identifiers

510(k) Number
K002280 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pediatric Electrode, Model PAD Pro 2602, is a reusable adhesive electrode designed for use with automated external defibrillators (non-wearable). It is intended for pediatric patients, providing a reliable interface for delivering defibrillation shocks during cardiac emergencies. This device adheres to the skin to ensure proper electrical conduction and is categorized under Class III medical devices due to its critical role in life-saving interventions.

The PAD Pro 2602 is supplied as a reusable component, intended for repeated use with proper cleaning and maintenance between applications. It is not sterile and must be cleaned according to manufacturer guidelines to prevent contamination. The device is regulated under FDA 510(k) clearance (K002280) and falls under the regulation number 870.5310, adhering to strict cardiovascular device standards. It is designed for compatibility with automated external defibrillators and is intended for use in emergency medical settings.

Frequently asked questions

Is the PAD Pro Pediatric Electrode intended for single-use or can it be reused after proper cleaning and maintenance?

The PAD Pro Pediatric Electrode (Model PAD Pro 2602) is designed for reusable use with automated external defibrillators. It must be cleaned and maintained between applications according to the manufacturer’s guidelines to ensure proper function and prevent contamination. Since it is not sterile, reuse requires adherence to cleaning protocols to maintain reliability and safety.

What types of automated external defibrillators is this pediatric electrode compatible with?

The PAD Pro Pediatric Electrode (Model PAD Pro 2602) is specifically designed for compatibility with non-wearable automated external defibrillators (AEDs). While the exact models aren’t listed, its regulatory classification under FDA 510(k) clearance (K002280) and association with cardiovascular defibrillation devices (via OpenFDA listings) confirms its intended use for emergency cardiac interventions in pediatric patients.

How should I store the PAD Pro Pediatric Electrode when not in use?

The device is not sterile and must be stored in a clean, dry environment to prevent contamination. Since it is reusable, storage should follow manufacturer guidelines to maintain its adhesive properties and electrical conductivity. Avoid exposure to extreme temperatures, moisture, or direct sunlight, as these could degrade performance over time.

What regulatory pathway was followed for FDA clearance of this pediatric electrode?

The PAD Pro Pediatric Electrode (Model PAD Pro 2602) received FDA 510(k) clearance (K002280) through a traditional review process by the Cardiovascular (CV) Advisory Committee. The device was determined to be substantially equivalent to a predicate, adhering to 21 CFR 870.5310 for cardiovascular defibrillation electrodes. This classification reflects its critical role in life-saving pediatric defibrillation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Devices Inc.
FDA Applicant
Medical Devices, Inc.

Sources (1)

  • FDA 510(k) K002280 24 fields · synced Sep 18, 2026